Risk Factors Affect Weight Loss Outcomes After Treatment.

NCT06482411 | Completed

• 1 other identifier: EMRP19113N
• Study Type: observational
• Target: 3,602
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment for weight loss was more diverse due to the higher prevalence of obesity. In addition to weight loss medications, many patients seek bariatric surgery to treat obesity. Although bariatric surgery was the most effective way, the patients still get weight gain due to failure to control their lives. The failure weight loss is caused by complex risk factors, such as dietary habits, quality of life, physical inactivity, comorbidities remission rate, and more related to the failure weight loss factors. To explore weight gain factors, the study uses many questionnaires, including demographic parameter and exercise frequency survey, the WHOQOL-BREF assessment, The Bariatric Quality of Life Questionnaire (BQL), the Three-Factor Eating Questionnaire (TFEQ-R18), the Yale Food Addiction Scale version 2.0 (YFAS 2.0), and Depression Anxiety Stress Scales-21 (DASS-21). The investigators assess different factors like quality of life, food addiction, preferences, psychological status, and regular examination parameters to identify reasons for unsuccessful weight loss. The study aims to establish the model for the prediction of risk factors after treatment of weight loss so that the tools will help to manage the best weight control for the future.

Conditions

Weight Regain

Keywords

Obesity; Weight regain; Bariatric surgery; Anti-obesity medications; Lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• The proportion of failure weight loss

  Compare the proportion of failure weight loss after bariatric surgery and medication plus life intervention at 1, 1.5, and 2 years.

  Month 6, Year 1, Year 1.5, Year 2

Secondary Outcomes (12)

• The percentage of total weight loss changes

  Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome

• Weight change

  Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome

• BMI change

  Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome

• Exercise change

  Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome

• Physiological parameter change

  Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome

Study Arms (4)

Non-Surgical group

Participants were treated with anti-obesity medications plus lifestyle intervention therapy Participants were treated with TFDA-approved anti-obesity medications (e.g. Saxenda, Contrave, etc.).

LSG

Bariatric surgery group(Restriction procedure): Laparoscopic Sleeve Gastrectomy

OAGB

Bariatric surgery group(Restriction procedure): One anastomosis gastric bypass

SASI

Bariatric surgery group(Restriction procedure): Single Anastomosis Sleeve Ileal Bypass

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

More than 30 BMI obese patients consent to join the study.

You may not qualify if:

• Once underwent bariatric surgery.
• Once used the GLP-1 receptor agonist.
• Pregnancy or preparation for pregnancy.
• Once and presenting gastric cancer.
• Presenting the other cancer.
• The abnormal endocrine system causes diseases with obesity.
• Major organ abnormalities (e.g., kidney failure, liver failure, heart failure, etc.).
• Gastric ulcer, and severe gastroesophageal reflux.
• Severe psychiatric disorders (schizophrenia, severe bipolar disorder, and depression, etc.).
• Bulimia nervosa or anorexia nervosa.
• Drug and alcohol abuse.
• Helicobacter pylori is not for bariatric surgery.
• The following diseases or conditions preclude the use of Contrave: 1)Uncontrolled hypertension, 2) History or current diagnosis of epilepsy, 3) Allergy to this medication, 4) Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).
• The following diseases or conditions preclude the use of GLP-1 medication: 1) History or current diagnosis of medullary thyroid carcinoma, 2)History or current diagnosis of Multiple Endocrine Neoplasia syndrome type 2, 3)Allergy to this medication, 4)Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).
• The following diseases or conditions preclude the use of Xenical medication: 1) History or current diagnosis of cholestasis, 2) Allergy to this medication, 3) Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

Chung-Yen Chen

Kaohsiung City, Yanchao District, 824, Taiwan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Administrative Offices Director

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 1, 2024
• Study Start: June 27, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

TW (1)